The comments by Ramesh and Haldar (1) point out several limitations of the Northern Manhattan Diabetes Community Outreach Project (NOCHOP), several of which we discussed at length in our original article (2). We do agree with their concern regarding the lack of statistical power, which we believe was mostly due to lower-than-expected intervention fidelity. Our participants experienced great difficulty attending the prespecified in-person sessions, therefore the NOCHOP community health workers actively engaged them in follow-up phone calls, which a post hoc analysis showed to be associated with greater HbA1c reduction.
There seems to be some confusion between the eligibility criteria and the sample we actually recruited. The NOCHOP inclusion criteria specified that people with poorly controlled diabetes, as determined by a recent HbA1c >8% (64 mmol/mol), were eligible to participate. We did not perform a repeat HbA1c measurement after enrollment and before randomization. Therefore, some participants did have an HbA1c <8% at their baseline evaluation visit. In retrospect, obtaining a point-of-care HbA1c measurement and restricting enrollment to those with elevated HbA1c might have been a better approach than the one we took.
NOCHOP was indeed the first randomized controlled trial attempting to extend use of the Small Steps, Big Rewards program from people with prediabetes to those with diabetes. However, if lack of precedence was always viewed as lack of validity, then there would be no innovation in science.
Finally, we also agree that our results and those of other randomized trials of community health worker interventions to improve diabetes care are best assessed collectively. There have been several well-designed randomized controlled trials published over the past few years in this field, and an updated systematic review and meta-analysis appears warranted.
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Duality of Interest. No potential conflicts of interest relevant to this article were reported.
